I had the opportunity to get to know Václav Klaus closely both as a patient and from our numerous discussions in which all talk of politics was barred (in the pub we both haunt, the sign “Politische Gespräche verboten” hangs over our table). This enabled me to gain a deeper insight into how Václav Klaus has managed to remain at the apex of politics for so long despite his many antagonistic attitudes towards majority opinion. I think the main reason is his entrenched ideological make-up, in which he has been assisted significantly by his wife. This gives him a clearly configured system for distinguishing and sorting information and processes (even those from completely different areas) in terms of their generality, subordination, specificity, variability, constancy and time-line (sequence), as he makes a distinction between what is short term, what is medium term, and what is long term. Another reason is that, both in the real world and in his (economic, political and civil) profession, he always tends to look for natural solutions to the processes he is studying rather than graft them onto highly specialized “expert” views, which are usually obstructive to comprehensive interpretations. This 21st-century trend of which he is so critical has also affected medicine and, ultimately, is paradoxically reflected in the health or sickness of presidents. It is the extraordinary availability of “expert (super-specialist)” approaches steeped in scientific evidence and related to forensic concerns (the if and the ergo...) which threatens the health of presidents more than the actual disease. In medicine, it should always be borne in mind that simple procedures respecting human nature are often more useful than encyclopaedic, science-based, but isolated knowledge. For these reasons, in my contribution I have focused on the meaning, limits and consequences of the current approach of “scientific” or “expert” medicine.

EVIDENCE-BASED MEDICINE (EBM): PARADIGM OR PARADOGMA?

Twenty-first-century medicine is a medicine that can draw on many technologies to diagnose, treat and cure numerous diseases. The empirically-based paradigm of humoral pathology lasted for two thousand years.

Today’s medicine cannot get by without science and technology, and added to that we can assume that biotechnology will play an increasing role. The current concept of science-based medicine reduces empirical knowledge. Instead, a methodologically grounded model of thinking is becoming increasingly prevalent. The effectiveness of most diagnostic and therapeutic procedures is reviewed by reference to the evidence; in this context, we refer to evidence-based medicine (EBM). As a result, medical procedures rely on objective science addressing, like physics, fully public, visible and transferable algorithms and templates, which it uses to promote its results. All evidential findings belong to a hierarchy; according to EBM recommendations, doctors should always be guided by the evidence highest up in the hierarchy. For example, meta-analyses and systematic reviews are higher than randomized and cohort studies, which are superior to case-control studies; in turn, these have a higher status than cross-sectional studies or case reports. Although this newly acquired scientific knowledge offers patients new opportunities and greatly expands the diagnostic and therapeutic options, it can hold the relationship between doctor and patient and the entire economic system in health care very much in thrall.

The aim of this contribution is to show the importance and limits of evidence-based medicine and to draw attention to certain consequences, including economic ramifications, that are implicit and imperceptible in the short term, but which are insidious and treacherous in that they shape stereotypes in our thinking. The healthcare system must encompass more than care for the sick based on scientific evidence, because a disease is not just a damaged chemical reaction or defective anatomical structure.

EBM AND THE SELF IN MEDICINE

In medicine, we cannot ignore the fact that, first and foremost, people are active subjects, not passive objects. Yet medicine focused on controlled research and armed with new technologies has started to approach the body as an impersonal machine, replacing medicine that treats the person as a whole. Treatment has been transformed into therapeutic technique. EBM medicine has slowly displaced the medicine of identity, which is able to dislodge itself from the strict dualism of body and mind. Mental states, consciousness and inner experience are excluded from evidence-based approaches because they are subjective, private and cannot be grasped in an exact manner. There is definitely no internal conflict in this respect; rather, there is a lack of coherence between external manifestations and internal states, with no joining of outer and inner intuition, no connection between space and time – not the space and time of physics, but space and time in relation to ourselves. Our inner experiences are nothing like a computer memory, but comprise the organization and categorization of personal episodes. In this light, medicine must also enter the realm of a patient’s genuine experience and transcend its purely workshop-based or veterinary approach.

Indeed, such poor cognitive processing of pain leads to negative emotions (anxiety, anger and depression), distressing behaviour and related chemical (immune, humoral, hormonal) processes in the body more than the intensity and unpleasantness of the pain itself. Conversely, the cognitive processing of pain as a challenge helps one to adapt to a pathological situation and leads to significantly better prospects of recovery. One of many examples is the continued existence of rituals associated with bloody processes (crucifixion, flagellation, initiation rituals, etc.). Their “victims” show no signs of pain, while the wounds, despite frequently unsterile treatment, heal very quickly and any scarring soon becomes hardly visible.

In this context, the emergence of diseases, injuries and other changes in human life cannot simply be limited to linear causality between the agent (noxa) of disease and a pathological condition. The biological component of the disease may be the primary factor, but there should also be more fundamental acceptance of the fact that people also respond to diseases with anxiety and fear, vegetative realignment, with humoral and immune reactions, cognitively induced emotional changes, changes in the way they view themselves, etc. These reactions often complicate and prolong the course of the disease and, as a tertiary effect, have negative social consequences. In contrast, social problems could trigger physical conditions that until then had been latent. Primary relationship problems and social issues that cannot be read and controlled emotionally are processed neurotically by the patient, who then experiences them in physical form. This can result in numerous somatic disorders. This could be defined as conversion or transformation from the mental plane to the somatic plane (psychosomatic illnesses).

In this regard, I would like to emphasize that the subjective space and its reaction (whether humoral, hormonal or immune, etc.) play a more significant role than that assigned to them in EBM approaches, and that the ambient influence, past experience, insight into the illness, cultural factors, effects of civilization and personal childhood experience (which I consider particularly important) should be appreciated more. As a result of these influences, numerous matters are overvalued and cognitively processed in a position of fear and anxiety, thus reducing immune, emotional and other areas of resilience. At this level, the standard of doctor–patient communication and the attitude of parents to disease or pain in the raising of their children must also be appreciated more.

Considering the present-day panic-stricken fear of illness, pain or infection, we should be asking ourselves how on earth we have managed to survive anything at all. “We ate sweets, buttered bread and dripping, sherbet foamed on our tongues, we drank drinks with real sugar and we were never overweight because we were always active outside, constantly on the go. Five or six of us had no qualms about sharing a soft drink, we all drank from the same glass and no one contracted an infection or fell ill... we drank water from garden hoses and other questionable sources... we picked fruit from the roadside and popped it straight in our mouths, and at the most we’d rub apples against our shirt... Our parents had to come outside and chase us home, and not vice versa...” (from František Novotný’s Buďme (Let’s) – a gift from Livia Klausová).

EBM AND SUPER-SPECIALIZATION

In the concept of evidence-based medicine, an imbalance between the quantity of often confusing incomplete knowledge, on the one hand, and the sluggish building of theories that allow for its efficient organization into larger units (a system), on the other, prevails. In other words, the analytical path of understanding carries the day over the synthetic path, i.e. the accumulation of detailed knowledge prevails over its organization into clearly arranged units. In practice, the default rule is “the narrower the problem, the greater the scientist”. This trend of the “atomization of scientific knowledge” has been apparent since the Second World War, but has increased exponentially since the 1990s, when staff at McMaster University first defined the concept of EBM. Since then, the impairment of the relative balance between the production of large quantities of scientific information and the development of systemic theories, or “big theories” (although beware of large-scale all-encompassing speculative theories), or at least the logically consistent and empirically corresponding “middle-range theories”, is becoming ever more distinct. The main reason for this is that the exploration of medicine’s broader systemic problems encounters more inaccuracies (“interference”), and thus carries less probative capacity than research into sub-processes that can accommodate strictly formulated, statistically testable theories. For example, we want to answer the question: “Does noise decrease immunity?” Here, examining how exposure to strong sound changes the white blood cells of a rat is definitely easier than exploring the impact of an urban environment on the local population’s immune system. When comparing a population group exposed to noise with a group from a quiet environment, differing only by that one parameter, the answer will be exact, but achieving a comprehensive answer will be much harder to back up with evidence due to the increased levels of input data and due to the inadequate or questionable methodology. Real intelligibility shrinks as the processes under examination become more complex, and by all accounts the complexity of human health and disease is enormous.

The exponential development of individual areas of knowledge and the concept of medicine as an applied science is better suited to a narrowly specialized expert focusing on a single aspect. Although a narrow specialization is not to be subjectively dismissed, it should be borne in mind that it results in severe limitations on knowledge across the field and loss of the concept of a person as a whole. On a practical level, it may offer highly complex, sophisticated solutions, but, in the context of the system, these solutions are actually often very simplified.

This trend, unfortunately, is mirrored by the teaching provided. The current priority is to breed an EBM approach early on, in the classroom. The aim is to shift away from an authoritarian style of teaching and steer the centre of learning towards working with information. These days, teachers do not then teach per se, but help students to navigate their way through a deluge of information. If we accept this principle (with great reservations on my part), teachers must be able to distinguish between what is essential and what is less essential, what is general and what is specific, what is constant and what is variable, and what is a system, a subsystem or a sub-subsystem. Without this ability, we will witness (and, regrettably, are already seeing) a lower standard of general education and flawed stereotypical thinking. The capacity to structure information systemically can be difficult to achieve because the habilitation and appointment of today’s professors and associate professors of medicine are primarily subject to quantitative indicators of scientific information.

The rank of teaching staff is determined primarily by the number of publications with an IF (impact factor – defined by the “average” number of citations made in a given period to an “averagely” cited article in a journal), the number of citations retrievable in a database of selected journals, especially Web of Science, PubMed (the MEDLINE database interface), and then, only marginally, their teaching skills (it is enough to have taught just a couple of lessons at a faculty) and their knowledge across the field or across medicine as a whole. In this light, professors and associate professors tend to be highly specialized scientists rather than educators (teachers ought to be evaluated according to their pupils’ IF factor, and only scientists should be judged by their own IF). Students thus learn more about a rare diagnosis, tumour or operation than, for example, about the effects of chronic pain on physical, behavioural and social processes.

EBM AND ETHICS

EBM must adequately meet ethical criteria if it is genuinely to serve medicine’s march forward. Full compliance with these criteria is patently difficult considering the complexity of the processes studied. For example, a blind or, even better, double-blind study is impossible to carry out in the absence of circumstances such as the presence of other diseases and risk factors, the variability of disease, patient and observer bias, different environmental conditions or the placebo effect, otherwise the “blinding” would be ethically questionable. Likewise, where the aim is to prove that medical treatment is not harmful, it may be necessary to evaluate the results over many years. Adverse consequences over time, induced by the excessive pharmacological influence (in terms of the effect) of immune, metabolic, and even unknown mechanisms, are again difficult to determine. Therefore, the “prematureness” of new treatments also figures among the serious ethical and, to some extent, methodological problems of EBM.

A particularly fundamental ethical problem concerns the interests of those who have guided a medicinal product, medical treatment, implant, etc., to the clinical stage at great expense, and the interest of those who will have an economic profit from the sale or application thereof. The sums in question commonly run into billions of dollars. In certain cases, medical propaganda based on experimental studies is capable of causing mass panic and stimulating high levels of spending. Sales of statins and fibrates (cholesterol-lowering drugs) alone earned manufacturers USD 27.8 billion in 2006. These drugs became the best selling drugs in history, despite their questionable impact on healthy people and the considerable negative consequences of their long-term pharmaceutical effect. In the propaganda and indications, regular exercise and a balanced diet were displaced and replaced. In the Czech Republic alone, they are used by almost a million people and are easily the most frequently used drugs. In the recent past, we have witnessed the hysteria and targeted manipulation surrounding swine flu (manufacturers earned up to USD 7 billion from the sale of swine flu vaccines), mad cow disease (tens of thousands of cows were culled), SARS... and the list goes on and on. There is nothing we can do if, sometime later, another clinical experiment, epidemiological study or simple reality shows that we were wrong or that there had been a carefully orchestrated campaign.

One more problem needs to be mentioned in the context of EBM and ethics. The level of acute medicine has risen and virtually the entire insurance system has made it possible to indicate treatment and invasive procedures of such a variety and scope that their sense and purpose need to be discussed. I am referring, by way of example, to complex surgical procedures among biologically elderly people, the biological treatment of end-stage cancer patients, and the rescue of infants with extremely low birth weight. The evidence advocating these procedures is based on the period of survival, neonatal mortality or exact, but often totally isolated, parameters (laboratory findings, radiographic results, scales of perceived pain, etc.), but it is not sufficiently judged in the context of the degree of disability, i.e. the patient’s chances of performing his or her customary range of activities. Nor is the extent of subsequent social disadvantage, known as “participation”, assessed. This is socially determined and represents the social consequences of health problems, reflecting quality of life after an injury or illness. Understandably, an objective evaluation is difficult. Ethically and economically, the solution to this problem must address the need for medicine to deliver not only treatment, but also an after-care process, limiting the degree of psychological, behavioural and social change to the level absolutely necessary, and creating alternative forms of such processes in the patient’s new living conditions. Contemporary medicine tends to concentrate on adding years to life when it should primarily be focusing on adding life to years.

In my view, we should also think more carefully about the fact that the possibilities and promotion of contemporary medicine (whether in the form of campaigns built on exaggerated fears or strategies detailing genuine medical opportunities) engender infinite demand for its services. EBM then has an excuse to meet this demand to an extent that will become economically unsustainable in the near future. This is a very serious problem (not only in the Czech Republic) in this area of the healthcare system that has been more or less glossed over in the drafts of various reforms. Unless adequate solutions are found to the related difficult ethical issues, EBM could soon take us economically captive, with little prospect of escape. Therefore, 21st-century medicine 21st century must consistently deal not only with medical practice, but also with issues to help a person in the terminal stage of life, issues of the scope (when to withdraw) and method of medical assistance in old age, issues of genetic engineering, as well as interventions, for example, in the reproduction of the human race, whether in the positive direction of eugenic efforts, or in respect of negative eugenic goals aimed at eliminating genetically well-defined diseases, etc. No one disputes the fact that the ethical point of view cannot be kept separate in the search of arguments for and against. The concept of contemporary medicine is not reducible to natural models, but should also promote the spiritual dimension with contributions from scientific, economic, technical and spiritual institutions and the corresponding subsystems extending from the family to the state.

Our relationship to death cannot be set aside from the handling of ethical issues and the shaping of our attitudes to illness. It is connected with all our actions; this is the only way to understand that suffering should be viewed not solely as misfortune, but also as an opportunity. The problem is that people close to death are unable to arrive at and resort to certain answers on their path to peace, as reason cannot go beyond visible reality and explore their foundations.

EBM AND OTHER E’S IN MEDICINE

In order to keep to a healthy course and avoid enslavement, there are other E’s which medicine must respect in full besides EBM – eminence, empiricism, experience, economy, ethics, and emotion-based medicine. None of them can be prioritized because they overlap each other. We must start by following the empirically acquired knowledge of our teachers (i.e. empiricism and eminence-based) and gradually factor in our own trial and error (experience-based), where possible comparing this with publications and, often, with economic limits (evidence-/economy-based). The other E’s are also significant (both the patient and the doctor are people struggling with subjectivism, often with a variety of conflicting emotions, etc.). While the preceding E’s are the priority, we should also accept that the doctor must take decisions not only on the basis of scientific knowledge, but also with a view to internal emotions and the moral aspects of the situation (emotive/ethically-based).

My wish for Václav Klaus on his birthday is that he not need medicine, and that, if he does, then that he benefit from medicine reliant not only on hard evidence, but also on healthy and natural reasoning.